(HealthDay)—The U.S. Food and Drug Administration said Tuesday that use of the CoreValve "valve-in-valve" aortic replacement has been expanded to include people at extreme risk for serious complications of traditional ...

In the first installment of a new series, Peter Doshi, Assistant Professor at the University of Maryland School of Pharmacy and Associate Editor at The BMJ, asks why authorities are approving drugs with little evidence they d ...

The marketing, prescribing and selling of testosterone and growth hormone as panaceas for aging-associated problems is disease mongering. So assert Thomas Perls, MD, MPH, FACP, a geriatrician at Boston Medical Center and ...

(HealthDay)—Cholbam (cholic acid) capsules have been approved by the U.S. Food and Drug Administration to treat adults and children with bile acid synthesis disorders and peroxisomal disorders, the agency said in a news ...

Federal health officials have approved the first lower-cost copy of a biotech drug to reach the U.S. market, a long-awaited milestone that could generate billions in savings for insurers, doctors and patients.

In an encouraging development for consumers worried about antibiotics in their milk, a new Food and Drug Administration study showed little evidence of drug contamination after surveying almost 2,000 dairy ...

The Food and Drug Administration is warning doctors against over-prescribing testosterone-boosting drugs for men, saying the popular treatments have not been established as safe or effective for common age-related ...

(HealthDay)—Unituxin (dinutuximab) has been approved by the U.S. Food and Drug Administration to treat children with high-risk neuroblastoma, a rare cancer that most often affects children aged five and under.

(HealthDay)—A mobile phone application (app) has been released to identify current drug shortages, resolved shortages, or discontinuations of drug products, according to a press release published by the ...

The manufacturer of a medical instrument at the center of a recent "superbug" outbreak in Los Angeles did not receive federal clearance to sell an updated version the device, according to officials from the Food and Drug ...

Food and Drug Administration (United States)

The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on products ranging from pet turtles to semen donations for assisted reproductive medicine techniques.